RecruitingPhase 1NCT07021157

A Study to Evaluate the Safety, Tolerability and PK of SK-08

A Randomized, Double-blind, Placebo-controlled, Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of Single-dose Increasing of SK-08 Tablets in Healthy Participants

Sponsor

Consun Pharmaceutical Group

Enrollment

48 participants

Start Date

Mar 9, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Disease(CKD)

Summary

The trial is conducted in a single-center, randomized, double-blind, placebo-controlled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) ,and pharmacodynamics (PD) characteristics of SK-08 in healthy participants.

Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This is an early-stage study (Phase I) testing the safety, tolerability, and how the body processes a new investigational drug called SK-08 in healthy volunteers. **You may be eligible if...** - You are a healthy adult between 18 and 45 years old - Your BMI is between 19 and 26 - You weigh at least 50 kg (men) or 45 kg (women) - You agree not to try to conceive during the trial and for 3 months after the last dose **You may NOT be eligible if...** - You have a history of allergies or are prone to allergic reactions - You have any chronic or serious illness affecting the heart, liver, kidneys, lungs, blood, immune, or hormonal systems - You are pregnant or breastfeeding - You are currently taking other medications or supplements that could interfere Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSK-08

Dose groups of 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg were given SK-08 once.

DRUGPlacebo

Dose groups of 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg were given placebo once.

Locations(1)

The First Affiliated Hospital，Zhejiang University

Hangzhou, Zhejiang, China

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NCT07021157

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